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Cowingene Mycoplasma Genitalium and Mycoplasma Hominis Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-ST12N3
Basic UDI-DI: B-ST12N3
Reference: ST12021X, ST12022X, ST12023W
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Group B Streptococcus Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-ST06N8
Basic UDI-DI: B-ST06N8
Reference: ST06011X, ST06012X, ST06013W
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

BGI

50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022021E6
Basic UDI-DI: B-SAC2022021E6
Reference: SAC2022021
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022020E4
Basic UDI-DI: B-SAC2022020E4
Reference: SAC2022020
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022019EK
Basic UDI-DI: B-SAC2022019EK
Reference: SAC2022019
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022004E6
Basic UDI-DI: B-SAC2022004E6
Reference: SAC2022004
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details

Releaser

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Xpedite Diagnostics GmbH
Manufacturer SRN: DE-MF-000020021
UDI-DI: 111816978037
Basic UDI-DI: PP12579.SWIFTX.MEDIA.26
Reference: SGR-25-IVD
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 14.07.2026 22:51

Manufacturer products View details

MYCOKIT SERO

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-PL10011MM
Basic UDI-DI: B-PL10011MM
Reference: PL10011
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: France
Authorised representative: -
Last updated: 14.07.2026 09:45

Manufacturer products View details

Mycoplasma IgM Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: D-MycoplasmaIgMLE
Basic UDI-DI: B-MycoplasmaIgMLE
Reference: Cassette
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 05:19

Manufacturer products Authorised representative products Authorised representative actors View details

Logix Smart MTB Test Kit

MTB-K-007

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Co-Diagnostics, Inc.
Manufacturer SRN: US-MF-000036425
UDI-DI: D-MTB-K-0074D
Basic UDI-DI: B-MTB-K-0074D
Reference: MTB-K-007
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Romania
Authorised representative: mdi Europa GmbH
Last updated: 14.07.2026 05:18

Manufacturer products Authorised representative products Authorised representative actors View details

MYCO WELL D-ONE LIQUI SCREEN

MS01349

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01349PZ
Basic UDI-DI: B-MS01349PZ
Reference: MS01349
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

Manufacturer products View details

INNODX TP Ab CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-TP-02100UY
Basic UDI-DI: B-KR-TP-02100UY
Reference: KR-TP-01200C
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX TB-IGRA CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-TB-IGRA-01050W7U
Basic UDI-DI: B-KR-TB-IGRA-01050W7U
Reference: KR-TB-IGRA-01050W
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX TB-IGRA CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-TB-IGRA-01020C65
Basic UDI-DI: B-KR-TB-IGRA-01020C65
Reference: KR-TB-IGRA-01020C
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

Chlamydia CEL PN IFA

KC3

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cellabs Pty Ltd
Manufacturer SRN: AU-MF-000030640
UDI-DI: D-KC3C2
Basic UDI-DI: B-KC3C2
Reference: KC3
EMDN: W0105010112
EMDN description: CHLAMYDIA PNEUMONIAE ANTIGEN DETECTION
First on market country: Germany
Authorised representative: WMDE B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

Chlamydia CEL PN IFA

KC3-B

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Cellabs Pty Ltd
Manufacturer SRN: AU-MF-000030640
UDI-DI: D-KC3-BTJ
Basic UDI-DI: B-KC3-BTJ
Reference: KC3-B
EMDN: W0105010112
EMDN description: CHLAMYDIA PNEUMONIAE ANTIGEN DETECTION
First on market country: Germany
Authorised representative: WMDE B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

Chlamydia CEL IFA

KC1-50T

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cellabs Pty Ltd
Manufacturer SRN: AU-MF-000030640
UDI-DI: D-KC1BW
Basic UDI-DI: B-KC1BW
Reference: KC1
EMDN: W0105010107
EMDN description: CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION
First on market country: Germany
Authorised representative: WMDE B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

Chlamydia CEL IFA (200T)

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cellabs Pty Ltd
Manufacturer SRN: AU-MF-000030640
UDI-DI: D-KC1-BT8
Basic UDI-DI: B-KC1-BT8
Reference: KC1-B
EMDN: W0105010107
EMDN description: CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION
First on market country: Germany
Authorised representative: WMDE B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema Pallidum Real Time PCR Kit

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB60108NW-50TUT
Basic UDI-DI: B-JB60108NW-50TUT
Reference: JB60108NW-50T
EMDN: W0105010305
EMDN description: SYPHILIS DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema Pallidum Real Time PCR Kit

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB60108NW-25TUT
Basic UDI-DI: B-JB60108NW-25TUT
Reference: JB60108NW-25T
EMDN: W0105010305
EMDN description: SYPHILIS DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details